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Nurses' Attitudes Toward Clinical Research: Experience of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials.

ABSTRACT: To understand factors affecting nurses' attitudes toward the Therapeutic Hypothermia After Pediatric Cardiac Arrest trials and association with approach/consent rates.Cross-sectional survey of pediatric/cardiac intensive care nurses' perceptions of the trials.Study was conducted at 16 of 38 self-selected study sites.Pediatric and cardiac intensive care nurses.The primary outcome was the proportion of nurses with positive perceptions, as defined by agree or strongly agree with the statement "I am happy to take care of a Therapeutic Hypothermia after Pediatric Cardiac Arrest patient". Associations between perceptions and study approach/consent rates were also explored. Of 2,241 nurses invited, 1,387 (62%) completed the survey and 77% reported positive perceptions of the trials. Nurses, who felt positively about the scientific question, the study team, and training received, were more likely to have positive perceptions of the trials (p < 0.001). Nurses who had previously cared for a research patient had significantly more positive perceptions of Therapeutic Hypothermia After Pediatric Cardiac Arrest compared with those who had not (79% vs 54%; p < 0.001). Of the 754 nurses who cared for a Therapeutic Hypothermia After Pediatric Cardiac Arrest patient, 82% had positive perceptions, despite 86% reporting it required more work. Sixty-nine percent believed that hypothermia reduces brain injury and mortality; sites had lower consent rates when their nurses believed that hypothermia was beneficial. Institution-specific approach rates were positively correlated with nurses' perceptions of institutional support for the trial (r = 0.54; p = 0.04), ICU support (r = 0.61; p = 0.02), and the importance of conducting the trial in children (r = 0.61; p = 0.01).The majority of nurses had positive perceptions of the Therapeutic Hypothermia After Pediatric Cardiac Arrest trials. Institutional, colleague, and study team support and training were contributing factors. Despite increased work, nurses remained enthusiastic demonstrating that studies with intensive bedside nursing procedures are feasible. Institutions whose nurses believed hypothermia was beneficial had lower consent rates, suggesting that educating nurses on study rationale and equipoise may enhance study participation.

SUBMITTER: Browning B

PROVIDER: S-EPMC4779735 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Nurses' Attitudes Toward Clinical Research: Experience of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials.

Browning Brittan B Page Kent E KE Kuhn Renee L RL DiLiberto Mary Ann MA Deschenes Jendar J Taillie Eileen E Tomanio Elyse E Holubkov Richard R Dean J Michael JM Moler Frank W FW Meert Kathleen K Pemberton Victoria L VL

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies 20160301 3

<h4>Objectives</h4>To understand factors affecting nurses' attitudes toward the Therapeutic Hypothermia After Pediatric Cardiac Arrest trials and association with approach/consent rates.<h4>Design</h4>Cross-sectional survey of pediatric/cardiac intensive care nurses' perceptions of the trials.<h4>Setting</h4>Study was conducted at 16 of 38 self-selected study sites.<h4>Subjects</h4>Pediatric and cardiac intensive care nurses.<h4>Measurements and main results</h4>The primary outcome was the propo ...[more]

PMID: 26669643

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Project description:The Therapeutic Hypothermia After Pediatric Cardiac Arrest trials will determine whether therapeutic hypothermia improves survival with good neurobehavioral outcome, as assessed by the Vineland Adaptive Behavior Scales Second Edition, in children resuscitated after cardiac arrest in the in-hospital and out-of-hospital settings. We describe the innovative efficacy outcome selection process during Therapeutic Hypothermia After Pediatric Cardiac Arrest protocol development.Consensus assessment of potential outcomes and evaluation timepoints.None.We evaluated practical and technical advantages of several follow-up timepoints and continuous/categorical outcome variants. Simulations estimated power assuming varying hypothermia benefit on mortality and on neurobehavioral function among survivors. Twelve months after arrest was selected as the optimal assessment timepoint for pragmatic and clinical reasons. Change in Vineland Adaptive Behavior Scales Second Edition from prearrest level, measured as quasicontinuous with death and vegetative status being worst-possible levels, yielded optimal statistical power. However, clinicians preferred simpler multicategorical or binary outcomes because of easier interpretability and favored outcomes based solely on postarrest status because of concerns about accurate parental assessment of prearrest status and differing clinical impact of a given Vineland Adaptive Behavior Scales Second Edition change depending on prearrest status. Simulations found only modest power loss from categorizing or dichotomizing quasicontinuous outcomes because of high expected mortality. The primary outcome selected was survival with 12-month Vineland Adaptive Behavior Scales Second Edition no less than two SD below a reference population mean (70 points), necessarily evaluated only among children with prearrest Vineland Adaptive Behavior Scales Second Edition greater than or equal to 70. Two secondary efficacy outcomes, 12-month survival and quasicontinuous Vineland Adaptive Behavior Scales Second Edition change from prearrest level, will be evaluated among all randomized children, including those with compromised function prearrest.Extensive discussion of optimal efficacy assessment timing, and of the advantages versus drawbacks of incorporating prearrest status and using quasicontinuous versus simpler outcomes, was highly beneficial to the final Therapeutic Hypothermia After Pediatric Cardiac Arrest design. A relatively simple, binary primary outcome evaluated at 12 months was selected, with two secondary outcomes that address the potential disadvantages of primary outcome.

Project description:ObjectivesTo describe telephone interview completion rates among 12-month cardiac arrest survivors enrolled in the Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital and Out-of-Hospital trials, identify key characteristics of the completed follow-up interviews at both 3- and 12-month postcardiac arrest, and describe strategies implemented to promote follow-up.SettingCentralized telephone follow-up interviews.DesignRetrospective report of data collected for Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, and summary of strategies used to maximize follow-up completion.PatientsTwelve-month survivors (n = 251) from 39 Therapeutic Hypothermia after Pediatric Cardiac Arrest PICU sites in the United States, Canada, and United Kingdom.InterventionsNot applicable.Measurements and main resultsThe 3- and 12-month telephone interviews included completion of the Vineland Adaptive Behavior Scales, Second Edition. Vineland Adaptive Behavior Scales, Second Edition data were available on 96% of 3-month survivors (242/251) and 95% of 12-month survivors (239/251) with no differences in demographics between those with and without completed Vineland Adaptive Behavior Scales, Second Edition. At 12 months, a substantial minority of interviews were completed with caregivers other than parents (10%), after calls attempts were made on 6 or more days (18%), and during evenings/weekends (17%). Strategies included emphasizing the relationship between study teams and participants, ongoing communication between study team members across sites, promoting site engagement during the study's final year, and withholding payment for work associated with the primary outcome until work had been completed.ConclusionsIt is feasible to use telephone follow-up interviews to successfully collect detailed neurobehavioral outcome about children following pediatric cardiac arrest. Future studies should consider availability of the telephone interviewer to conduct calls at times convenient for families, using a range of respondents, ongoing engagement with site teams, and site payment related to primary outcome completion.

Project description:BackgroundSeparate trials to evaluate therapeutic hypothermia after paediatric cardiac arrest for out-of-hospital and in-hospital settings reported no statistically significant differences in survival with favourable neurobehavioral outcome or safety compared to therapeutic normothermia. However, larger sample sizes might detect smaller clinical effects. Our aim was to pool data from identically conducted trials to approximately double the sample size of the individual trials yielding greater statistical power to compare outcomes.MethodsCombine individual patient data from two clinical trials set in forty-one paediatric intensive care units in USA, Canada and UK. Children aged at least 48 h up to 18 years old, who remained comatose after resuscitation, were randomized within 6 h of return of circulation to hypothermia or normothermia (target 33.0 °C or 36.8 °C). The primary outcome, survival 12 months post-arrest with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score at least 70 (scored from 20 to 160, higher scores reflecting better function, population mean = 100, SD = 15), was evaluated among patients with pre-arrest scores ≥70.Results624 patients were randomized. Among 517 with pre-arrest VABS-II scores ≥70, the primary outcome did not significantly differ between hypothermia and normothermia groups (28% [75/271] and 26% [63/246], respectively; relative risk, 1.08; 95% confidence interval [CI], 0.81 to 1.42; p = 0.61). Among 602 evaluable patients, the change in VABS-II score from baseline to 12 months did not differ significantly between groups (p = 0.20), nor did, proportion of cases with declines no more than 15 points or improvement from baseline [22% (hypothermia) and 21% (normothermia)]. One-year survival did not differ significantly between hypothermia and normothermia groups (44% [138/317] and 38% [113/ 297], respectively; relative risk, 1.15; 95% CI, 0.95 to 1.38; p = 0.15). Incidences of blood-product use, infection, and serious cardiac arrhythmia adverse events, and 28-day mortality, did not differ between groups.ConclusionsAnalysis of combined data from two paediatric cardiac arrest targeted temperature management trials including both in-hospital and out-of-hospital cases revealed that hypothermia, as compared with normothermia, did not confer a significant benefit in survival with favourable functional outcome at one year.

Project description:To assess the feasibility, effectiveness, side effects, and adverse events associated with a standardized surface cooling protocol. Induced therapeutic hypothermia after pediatric cardiac arrest is an important intervention.Prospective intervention trial.Urban, tertiary care children's hospital.Twelve pediatric cardiac arrest survivors.Standardized surface cooling protocol.Patients (age: median, 1.5 yrs; interquartile range, 0.5-6.25; cardiopulmonary resuscitation duration: median, 18 mins; interquartile range, 10-45) were cooled by a standard surface cooling protocol for rapid induction and maintenance of goal rectal temperature (T) 32°C-34°C for 24 hrs, with prospectively defined rescue protocols. Side effects and clinical interventions were recorded. Median time to rectal T ?34°C was 1.5 (1, 1.5) hrs from cooling initiation and 6 (5, 6.5) hrs from arrest. T was documented every 30 mins. Maintenance target T 32°C-34°C was attained in 78% (414 of 531) of measurements, overshoot hypothermia <32°C in 15% (81 of 531), and overshoot hyperthermia >34°C in 7% (36 of 531). Mean bias between rectal vs. esophageal T was -0.42°C (95% confidence interval, -0.49 to -0.35), and between rectal and bladder T was 0.16°C (95% confidence interval, 0.11-0.22). Side effects observed included: hypokalemia <3.0 mEq/L in 67% of patients and bradycardia <2% for age in 58%. There were no episodes of bleeding or ventricular tachyarrhythmia that required treatment. Six (50%) of 12 patients survived to discharge.A standard surface cooling protocol achieved rapid induction of hypothermia after pediatric cardiac arrest. During maintenance of hypothermia, 78% of measures were within target T 32°C-34°C. Commonly employed temperature sites (esophageal, rectal, and bladder) were similar. Overshoot hypothermia and associated side effects were common, but there were no serious adverse events attributable to induced therapeutic hypothermia in this case series. Surface cooling protocols to induce and maintain therapeutic hypothermia after pediatric cardiac arrest are potentially feasible.

Dataset Information

Nurses' Attitudes Toward Clinical Research: Experience of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials.

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Nurses' Attitudes Toward Clinical Research: Experience of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials.

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